[00:00:05] Speaker 01:
We have six cases on the calendar this morning.

[00:00:09] Speaker 01:
Four of them patent cases, two from district courts and two from the PTAB.

[00:00:15] Speaker 01:
Tax case from the Court of Federal Claims and the veterans case.

[00:00:22] Speaker 01:
The veterans case and one of the patent cases will be submitted only in the briefs and not be argued.

[00:00:31] Speaker 01:
First case.

[00:00:33] Speaker 01:
Is Enzo life sciences versus the logic and Beckton Dickinson, 2018, 1232 and 1233.

[00:00:40] Speaker 01:
Mr.

[00:00:48] Speaker 03:
Good morning, Your Honor, and may it please the Court, Justin Wilcox of the Marist LLP on behalf of Appel and Enzo.

[00:00:53] Speaker 03:
The Board committed three critical errors in concluding that the challenge claims of the 197 patent are unpatentable.

[00:00:59] Speaker 03:
First, the Board's adherency to his decision lacked any evidence, much less substantial evidence.

[00:01:04] Speaker 03:
There is no evidence in the record that the nucleic acids in the fish reference are bound in a manner that would render them capable of hybridization and significantly- Why not?

[00:01:14] Speaker 01:
Your Honor, there's no actual evidence that the bases are free to combine.

[00:01:25] Speaker 03:
That's the critical error.

[00:01:27] Speaker 01:
There's no evidence that they are not.

[00:01:30] Speaker 01:
So the reference stands for, shows the possibility, capability of binding.

[00:01:40] Speaker 03:
Your Honor, under this court's precedent with respect to inherency, the possibility or probability of hybridization is not enough.

[00:01:49] Speaker 03:
It must be unavoidably capable of hybridizing.

[00:01:54] Speaker 03:
And the evidence is lacking on that point, specifically.

[00:01:58] Speaker 05:
Haven't we said that it only has to be inherently capable to the extent disclosed in the patent?

[00:02:08] Speaker 03:
Your Honor, the court has said that, but there's no evidence that the protocol that was performed in the fish reference is the same as the protocol that was performed in the 107 patent.

[00:02:19] Speaker 02:
And I guess that's the problem or concern I have with your argument.

[00:02:24] Speaker 02:
Your claimed support is coded with something like PPL, right?

[00:02:29] Speaker 02:
Correct, Your Honor.

[00:02:30] Speaker 02:
And the fish reference, its support is coded by PPL.

[00:02:39] Speaker 02:
Your expert explained how, thanks to the coding of PPL, some single strand DNA can bind to the support along the phosphate backbone of the single stranded DNA against the positively charged coding on the support.

[00:03:02] Speaker 02:
And that's precisely what FISH has, the PPL coding, which would allow, why wouldn't that likewise allow FISH's single-stranded DNA to rely on its phosphate backbone to bind up against its support?

[00:03:20] Speaker 03:
Your Honor, I would disagree with your premise, respectfully.

[00:03:23] Speaker 03:
Our expert described how another example in the 197 patent using a glass slide in a different coding gamma APS would result in that.

[00:03:34] Speaker 03:
But there's no actual evidence in the record that the way that nucleic acids are bound by PLL would render the

[00:03:43] Speaker 03:
the bases available for hybridization.

[00:03:44] Speaker 03:
That's really the critical problem with the inherency finding here.

[00:03:49] Speaker 03:
Petitioner could have done things like try to replicate the FISH experiment to show that this would be inherent property, but they didn't do that.

[00:03:56] Speaker 02:
So what's wrong with the theory of your disclosure talks about coding your support with PPL, PLL, whatever you want to call it, and FISH does the same thing.

[00:04:07] Speaker 02:
It uses a PPL coding.

[00:04:11] Speaker 02:
And your spec says, and so therefore, you're going to have your single-stranded DNA bind to the support, and it'll be hybridizable.

[00:04:24] Speaker 02:
So why wouldn't that same outcome be true for fish using its PPL coding?

[00:04:31] Speaker 03:
You know, there are two issues there.

[00:04:33] Speaker 03:
Number one, again, there's no evidence that they're the same protocol.

[00:04:36] Speaker 03:
That's important.

[00:04:37] Speaker 02:
There is no protocol disclosing your patent, nor is it claimed.

[00:04:43] Speaker 02:
It's just have the coding.

[00:04:45] Speaker 02:
There's no description of, oh, I need a certain...

[00:04:48] Speaker 02:
concentration of the PPL or you have to apply it in this particular manner under this particular temperature.

[00:04:55] Speaker 02:
There's nothing like that in your patent spec.

[00:04:57] Speaker 02:
It's just about apply the coding.

[00:04:59] Speaker 02:
So again, I'm trying to understand from you

[00:05:04] Speaker 02:
Why wouldn't we have the same outcome here?

[00:05:06] Speaker 03:
Your Honor, there are two issues there.

[00:05:09] Speaker 03:
So there are some differences between the two.

[00:05:12] Speaker 03:
First of all, in fish, it describes coating the service at room temperature.

[00:05:16] Speaker 03:
In the patent, it actually describes coating the service at 37 degrees Celsius.

[00:05:21] Speaker 03:
But going back, there's just no actual evidence that what was done in fish would result in nucleic acids capable of binding because their bases were available.

[00:05:33] Speaker 05:
But it only says capable and the board said you don't need actual hybridization, you just need the capability and you say in your own spec that the coding gives it the capability.

[00:05:46] Speaker 05:
So what more would fish need to say?

[00:05:50] Speaker 03:
Your honor, Fish would need to say, or the petitioner would need to come forward and show that the bases are actually available for binding in Fish.

[00:06:00] Speaker 03:
And that isn't in the record.

[00:06:02] Speaker 03:
What petitioner points to is the 197 patent for that premise, and it's not there.

[00:06:09] Speaker 03:
And they also point to another reverence called Deal.

[00:06:11] Speaker 03:
In fact, their expert relied heavily on Deal.

[00:06:14] Speaker 05:
They also got to know the prosecution history of the 197.

[00:06:17] Speaker 03:
To correct, Your Honor, the prosecution history describes, you know, coatings in general of being capable of doing this, but it also described how, you know, once these coatings were perfected, they were capable of doing this.

[00:06:28] Speaker 03:
But there's no evidence that, you know, the coatings in fish were perfected.

[00:06:33] Speaker 05:
I'd like to move to the... They said in prosecution history that coatings make you capable.

[00:06:40] Speaker 05:
Yes, they might be more capable with a perfected coding, but there was nothing in the specification or the prosecution history that says they're not capable with a non-perfected coding.

[00:06:54] Speaker 03:
You're right.

[00:06:55] Speaker 03:
There's nothing that says they're not capable.

[00:06:57] Speaker 03:
But the level of proof for inherency is very high.

[00:07:01] Speaker 03:
And so it's always been petitioner's burden to come forward and show why the nucleic acids of fish would unavoidably result in the capability to bind.

[00:07:11] Speaker 03:
And they haven't showed that.

[00:07:11] Speaker 03:
And the one way they could do that was to show.

[00:07:13] Speaker 01:
Well, that's what nucleic acids do when there's the presence of a complementary base.

[00:07:23] Speaker 01:
They bind.

[00:07:24] Speaker 03:
Your honor, not.

[00:07:25] Speaker 01:
It isn't inherency.

[00:07:27] Speaker 01:
Well, it's inherent in their chemical nature.

[00:07:32] Speaker 03:
Your Honor, the Board recognized that this is not necessarily the case.

[00:07:37] Speaker 03:
The Board corrected its original paying instruction to clarify that nucleic acids could be bound in either a form that renders them hybridizable, such as if they're bound by their phosphate backbone, or that they could bound in a way that renders them not capable, such as through their bases.

[00:07:52] Speaker 01:
And so our point is... That's right, in which case they wouldn't be available for a complementary binding.

[00:07:57] Speaker 03:
Correct, Your Honor.

[00:07:58] Speaker 01:
You wanted to get to another point.

[00:08:00] Speaker 03:
Your Honor, I'd just like to follow up and finish that point, that that's a critical piece that's missing, is evidence showing that actually the bases are available.

[00:08:08] Speaker 03:
That's not the record.

[00:08:09] Speaker 03:
I'd like to touch on the board's errors with respect to its motivation combined findings.

[00:08:16] Speaker 03:
They can be sustained by substantial evidence, and that's because they either articulated an entirely conclusive reason to combine, or no reason to combine the disparate references at all.

[00:08:27] Speaker 03:
For example, with the VPK and Ramachandran annoys references, the board on Appendix 50 just recites an entirely conclusory statement of how the references could be combined, but never actually says the reason why somebody would do that.

[00:08:42] Speaker 05:
Do we even need to get to VPK if we think that the analysis as it relates to fish was correct?

[00:08:49] Speaker 03:
Yes, Your Honor, there are certain claims that would be, that are not affected by the fish reference, and the VPK combination would apply.

[00:09:00] Speaker 02:
Which claims are those?

[00:09:04] Speaker 03:
Your Honor, those would be the covalent fixation claims, 38, 78, 113, 185, and 218.

[00:09:16] Speaker 05:
What are the claims?

[00:09:17] Speaker 05:
What are the numbers?

[00:09:18] Speaker 03:
Your Honor, those were claims 38, 78, 113.

[00:09:22] Speaker 01:
Well, 38 doesn't depend on VPK.

[00:09:25] Speaker 01:
38, Fish and Gillum relate to 38.

[00:09:31] Speaker 03:
Your Honor, I'm also going to address those as well.

[00:09:34] Speaker 03:
But the critical problem with both the VPK, Ramachandran noise combinations in the Fish and Gillum references

[00:09:41] Speaker 03:
is that there's no glue to hold these together.

[00:09:43] Speaker 03:
And that's important because the base reference that the petitioner was pointing to and the board ruled on was a porous system.

[00:09:52] Speaker 03:
And that's key because, for example, in Noyes and Gillum, the nucleic acids are bound and hybridized in the pores of a porous support, which is the conventional method at the time.

[00:10:01] Speaker 03:
But there's no glue, as this court called it, for jumping to a non-porous system, to take those teachings in a porous system and apply them to a non-porous system.

[00:10:11] Speaker 03:
And there were problems there because, as our expert pointed out, what the board didn't address.

[00:10:18] Speaker 03:
Noise specifically used this porous system because of the high capacity for binding.

[00:10:24] Speaker 03:
That's not the case with a non-porous support.

[00:10:27] Speaker 03:
But in any event, the board did not actually address these specific reasons that Enzo articulated for why skilled artisan would not have even selected these references for combination in the first place.

[00:10:38] Speaker 03:
And that applies to both

[00:10:40] Speaker 03:
the VPK noise and combinations in the fish and gillum combinations.

[00:10:46] Speaker 03:
I'd like to move to the priority arguments.

[00:10:52] Speaker 03:
The priority issue is straightforward.

[00:10:54] Speaker 03:
The board did not

[00:10:56] Speaker 03:
apply the correct legal standard in assessing whether the original application in the priority chain provided a written description for the non-poor limitations.

[00:11:05] Speaker 03:
The board didn't assess the level of predictability.

[00:11:08] Speaker 03:
It also didn't assess the knowledge of a skilled artisan, which is required in this court's opinion of Bilstowd v. Workopolis.

[00:11:15] Speaker 03:
And that created error because the board just jumped straight to

[00:11:20] Speaker 03:
analyzing the proof that we put forward in isolation and saying it's not probative, but the board couldn't assess properly whether that proof was probative before first making findings on the level of predictability in the field and the knowledge of a skilled artist.

[00:11:34] Speaker 03:
I'd like to see them into my rebuttal time.

[00:11:36] Speaker 02:
Before we go, which claims are not covered by the fish-based objections?

[00:11:47] Speaker 02:
You said 38 and 78, but those are covered by the Fish Gillum combination.

[00:11:53] Speaker 02:
So is there any claim that the VPK-based projections reach that the Fish-based projections don't?

[00:12:01] Speaker 03:
Your Honor, I believe there are, and I will check and get back to you in my rebuttal on that point.

[00:12:08] Speaker 01:
That'll be fine.

[00:12:10] Speaker 06:
Mr. Saunders.

[00:12:13] Speaker 06:
Tom Saunders, Rebecca Dickinson.

[00:12:15] Speaker 04:
Can you answer that question first?

[00:12:17] Speaker 04:
Are there any that are not covered by the board?

[00:12:19] Speaker 06:
No.

[00:12:20] Speaker 06:
So the board carefully analyzed the evidence and invalidated each claim on at least two independent grounds.

[00:12:28] Speaker 06:
Every single claim is reached by the fish grounds, with fish and gillum being used for 3878 and 218.

[00:12:35] Speaker 06:
And then independently, every single claim is reached by one of the people.

[00:12:41] Speaker 05:
So if we affirmed on the

[00:12:42] Speaker 05:
fish grounds, then the priority of BPK or BPK as prior art is irrelevant.

[00:12:48] Speaker 06:
Exactly.

[00:12:49] Speaker 06:
And so the only argument made today that would go would be those last three dependent claims on the fish grounds, which was about the motivation to combine with Gillum.

[00:13:01] Speaker 06:
And the argument that there isn't motivation here is simply incorrect.

[00:13:08] Speaker 06:
The board

[00:13:09] Speaker 06:
at page 34 of the appendix credited our experts' testimony that there was motivation to use the covalent bonds of Gillum, because it was known that the covalent bonds were stronger.

[00:13:23] Speaker 06:
And so there was an express finding of motivation there, also the fact that Gillum and Fish were both connecting through the amine groups.

[00:13:33] Speaker 06:
In terms of the noise and VPK, there also was evidence on

[00:13:39] Speaker 06:
motivation there in terms of the ease of using glass slides and the desirability of having something that can be used with a microscope and would allow for visualization.

[00:13:52] Speaker 06:
So again, there was expert testimony on this point.

[00:13:54] Speaker 06:
Substantial evidence supports the board's finding there.

[00:13:57] Speaker 05:
The board's motivation to combine finding was a little bit odd.

[00:14:02] Speaker 05:
I mean, they really just faulted ENSO for focusing on

[00:14:07] Speaker 05:
the individual references, but you cite a lot of evidence that you say is substantial evidence, but the board didn't actually cite to that evidence that you point us to now, did it?

[00:14:17] Speaker 06:
Well, I think it's baked into an appendix 50.

[00:14:22] Speaker 06:
The board talks about the motivation to combine using noise on easy to use, non-porous supports.

[00:14:33] Speaker 06:
And at the end of that paragraph, it's citing our petition on pages 52 through 53, and then exhibit 1002, which is our expert declaration, paragraphs 105 through 107 of that declaration.

[00:14:48] Speaker 06:
So I don't think that the board's opinion is devoid of this.

[00:14:52] Speaker 06:
It was relying on our expert declaration and the motivation that was prior there for the noise VPK ground.

[00:15:03] Speaker 05:
to the extent that the law requires an articulation of the basis, we have a baked-in standard now?

[00:15:10] Speaker 06:
No, no, not a baked-in standard.

[00:15:11] Speaker 06:
The motivation on the face of the board's decision, it's talking about the motivation for, you know, specifically says, motivated with a reasonable expectation of success to perform the nucleic acid hybridization experiments described in NOISE on easy-to-use non-porous supports

[00:15:30] Speaker 06:
such as the glass slides disclosed in VPK.

[00:15:35] Speaker 06:
And what I'm saying is baked in.

[00:15:36] Speaker 06:
At the end of that paragraph, it then is citing our expert declaration, which is elaborating on what it means by easy to use and the motivation to use the glass slides for visualization there.

[00:15:51] Speaker 01:
Council, if we don't agree with you that the first references dispose of all the claims, then VPK becomes important.

[00:16:01] Speaker 01:
And why didn't the board err in finding that the 1983 patent application was sufficient to describe, provide written description for a non-porous solid support?

[00:16:20] Speaker 01:
It described polystyrene.

[00:16:22] Speaker 01:
It described glass.

[00:16:25] Speaker 01:
And non-porous solid support isn't like a chemical genus.

[00:16:30] Speaker 01:
where you have to show possession of species within the genus.

[00:16:36] Speaker 01:
Non-porous solid support is an item, an object described by its name.

[00:16:44] Speaker 01:
And even if it were a genus, species anticipate a genus.

[00:16:50] Speaker 01:
And the 1983 patent application does describe certain species.

[00:16:57] Speaker 01:
So why wasn't the board in error in not providing entitlement to the benefit of the 1983 patent application?

[00:17:07] Speaker 06:
So the board's written description finding, which is reviewed as a question of fact here, was looking at an application that disclosed some supports that happened to be non-porous.

[00:17:20] Speaker 06:
and other supports that happen to be porous.

[00:17:24] Speaker 06:
And doing so in a manner that was not showing anything sort of special or tying together the genus.

[00:17:32] Speaker 06:
This is what we've talked about in terms of blaze marks here.

[00:17:35] Speaker 06:
Nothing to say we are not just happening to discuss a few supports that happen to be non-porous, but rather we have possession here.

[00:17:46] Speaker 06:
Part of our invention is the entire genus

[00:17:50] Speaker 06:
of non-porous supports.

[00:17:51] Speaker 06:
Our expert talked at page 2783 of the appendix in his deposition about some of the non-porous supports in this genus of all possible non-porous supports that weren't included.

[00:18:05] Speaker 01:
But if you have a claim to a passenger vehicle and a prior reference, which one in Title I, II describes an automobile,

[00:18:16] Speaker 01:
Isn't that adequate written description for a passenger vehicle?

[00:18:22] Speaker 01:
Isn't it analogous?

[00:18:24] Speaker 01:
Here you've got a non-porous solid support and the 83 patent application describes a couple.

[00:18:31] Speaker 01:
The fact that it may also have described porous ones isn't an issue because we're not dealing with porous, we're dealing with non-porous.

[00:18:41] Speaker 06:
But it then is going

[00:18:44] Speaker 06:
to that broader genus of all of the non-porous solid sports.

[00:18:50] Speaker 01:
You're stopping the premise that it's a genus rather than the description of an item.

[00:18:58] Speaker 06:
Right, it's a description of an item, but they didn't claim

[00:19:05] Speaker 06:
the items they had or those particular attributes, they have gone very broad in their claims to try to get to all of non-porous.

[00:19:15] Speaker 06:
And it's clear when you get to their 1985 application that that's an attribute they have.

[00:19:20] Speaker 02:
Let me try a different car-related analogy.

[00:19:22] Speaker 02:
What if the earlier application disclosed

[00:19:26] Speaker 02:
automatic cars and manual stick shift cars.

[00:19:30] Speaker 02:
And then four years later, they claim manual stick shift cars.

[00:19:37] Speaker 02:
That would be a written description violation?

[00:19:40] Speaker 06:
No, but I think the key here is they don't disclose it in those terms.

[00:19:46] Speaker 06:
We're not saying you have to use the exact

[00:19:48] Speaker 06:
terms the analogy would be they've disclosed six cars very specific make model number three of them happen to be automatic three of them happen to be stick shift to the extent the specification is saying sort of what do we have possession of the focus is on transparent or translucent it's not on the

[00:20:12] Speaker 06:
switching back to our actual facts here, not on the particular attribute of being non-porous.

[00:20:19] Speaker 01:
In any event, your ultimate point is it doesn't matter because your view is we don't need to deal with VPK, we just need to deal with FISH because FISH and the other references are radical.

[00:20:32] Speaker 06:
Absolutely.

[00:20:33] Speaker 06:
That alone gets the full path to affirmance on all of the claims here.

[00:20:38] Speaker 02:
Can you speak on the inherency of the hybridizable limitation in fish?

[00:20:42] Speaker 06:
Right.

[00:20:43] Speaker 06:
So the inherency here, our expert, Dr. Nelson, testified about the PLL coding in fish is going to put down a layer of positive charge amines.

[00:20:57] Speaker 06:
And the way that those bind

[00:21:00] Speaker 06:
with the nucleic acid is what's driving the inherency, which is that they bind with the phosphate group, the negatively charged phosphate group in the phosphate sugar backbone, which then leaves the bases free for hybridization.

[00:21:17] Speaker 06:
And there's no challenge to the board's claim construction here, which is we're not talking about requiring actual hybridization or the hybridization conditions.

[00:21:27] Speaker 06:
These claims are designed to read on the articles of manufacture, have hybridizable form, which was construed to mean single-stranded and have the bases available.

[00:21:39] Speaker 05:
Well, what's your response to your friend's argument that actually it's a perfected hybridizable form that is being claimed?

[00:21:48] Speaker 05:
So there's a, I know the board didn't

[00:21:51] Speaker 05:
didn't think that there was a limitation that talked about the temperature degrees, but could there be different forms that are disclosed in the two different pieces, the two different references?

[00:22:05] Speaker 06:
But the claims themselves are reading on any of these nucleic acids, incredibly broad claims, any nucleic acid in hybridizable form.

[00:22:17] Speaker 06:
And so the

[00:22:19] Speaker 06:
straight from the fish reference and the expert testimony about the chemistry and the binding here gets you to the inherency on hybridizable form.

[00:22:31] Speaker 06:
And then looking at the deal reference, looking at their own application, the fact that they don't disclose any of the conditions was confirmation that every time they looked out there to see something with this PLL coding,

[00:22:48] Speaker 06:
there was hybridization or these emissions in the prosecution history.

[00:22:54] Speaker 05:
But I wonder if we were here in a claim construction analysis, and your argument was we don't infringe because we don't do it exactly the same way.

[00:23:02] Speaker 05:
You'd be saying that, well, they inherently disclose the rest of it.

[00:23:07] Speaker 05:
They inherently claim a narrower claim because the specification is so rife with these details.

[00:23:13] Speaker 06:
Well, we're not here on an acclaimed construction analysis because they haven't argued it.

[00:23:18] Speaker 06:
And I don't think we would be plausibly arguing that the specification is rife with details.

[00:23:24] Speaker 06:
The specification is noticeably lacking details.

[00:23:27] Speaker 06:
Council has mentioned the temperature.

[00:23:29] Speaker 06:
That's it that you would find in the specification.

[00:23:34] Speaker 06:
It really is this bare reference to PLL.

[00:23:37] Speaker 06:
And that was what was being touted in the prosecution history.

[00:23:42] Speaker 01:
Thank you, counsel.

[00:23:44] Speaker 01:
We'll hear from the government as intervenor on the constitutional issue.

[00:23:49] Speaker 00:
How are you doing, your honor?

[00:23:51] Speaker 00:
Good morning.

[00:23:51] Speaker 00:
May I please the court?

[00:23:52] Speaker 00:
Dennis Vann on behalf of the government, as you mentioned.

[00:23:55] Speaker 00:
on the constitutional issues in the case.

[00:23:58] Speaker 00:
As the panel is likely aware, there's a number of pending cases where these same precise constitutional issues have already been raised before the court.

[00:24:07] Speaker 00:
And there are also a number of pending appeals where the issues have been properly preserved

[00:24:14] Speaker 00:
before the board, before they're raised here.

[00:24:17] Speaker 00:
And so this court is obviously within its discretion to decide the issues in any of those cases.

[00:24:23] Speaker 00:
It's within its discretion to decide them here.

[00:24:25] Speaker 00:
Of course, the government would prefer that the court reach them in a case where they were properly preserved and where the patent owners, in fact, raised the issue before the board so that- I think those cases have been argued already.

[00:24:39] Speaker 00:
There haven't been any.

[00:24:40] Speaker 00:
The most advanced one that I know of right now is Agribol v. Topgolf, which is number 18-2270 here in the Federal Circuit.

[00:24:49] Speaker 00:
I think it's still awaiting reply briefing.

[00:24:53] Speaker 00:
That's the one that's been preserved.

[00:24:55] Speaker 00:
The number of cases total that have raised these constitutional issues that have been argued

[00:25:01] Speaker 00:
I think we're approaching 10 or so.

[00:25:04] Speaker 00:
I'm not exactly sure on the precise numbers, but as the government has mentioned in its briefing, all of that goes to show that if this court wants to avert the uncertainty of whether or not inter-part case review is constitutional or not, it can certainly do so.

[00:25:20] Speaker 00:
And we think that that issue is easily resolved by this court's precedent and PatLex, which is materially indistinguishable and upheld ex parte re-examination against similar, if not the exact same types of challenges.

[00:25:39] Speaker 00:
And if this court doesn't have questions on the merits of that, I'm happy to see the rest of my time.

[00:25:48] Speaker 01:
Thank you, Mr. Fan.

[00:25:51] Speaker 01:
Mr. Wilcox takes even more bubble time.

[00:25:57] Speaker 03:
Your Honor, turning back to the various grounds, I was a little confused.

[00:26:04] Speaker 03:
The fish grounds do cover all of the claims, and the VBK grounds cover all the array claims.

[00:26:10] Speaker 03:
I just wanted to point out that there is a certain subset where the obvious combinations are critical, and those would be claims 38, 78, 218, 113, and 185 are not covered by fish alone, and claims 38, 78, and 218 are not covered by VBK alone.

[00:26:26] Speaker 03:
I'd just like to turn back to the inherently issues briefly.

[00:26:31] Speaker 03:
I think it's critical that we recognize that the amount of written description and specification required for enabling written description is different.

[00:26:41] Speaker 03:
than the standard for finding inherency.

[00:26:45] Speaker 03:
Inherency must be an unavoidable result when it comes to the 112 issues.

[00:26:50] Speaker 03:
It needs to either reasonably convey for indescription or convey without undue experimentation for enablement.

[00:26:57] Speaker 05:
With respect to the question of what has to be inherent, didn't the board specifically find that the temperatures that you referenced before were not required by the claims?

[00:27:09] Speaker 03:
Your Honor, you're correct.

[00:27:11] Speaker 03:
They're not required by the claims.

[00:27:13] Speaker 03:
I'm not identifying the hybridization conditions.

[00:27:15] Speaker 03:
I'm pointing to the actual protocol used to treat the solid support with the PLL coating.

[00:27:23] Speaker 03:
So that's different than the board was assessing an argument that we made there about the conditions of hybridization and the temperature weren't known here.

[00:27:30] Speaker 03:
What the temperature I'm pointing to is just with how the PLL is affecting.

[00:27:33] Speaker 05:
Well, what did you claim then that was special about the coating?

[00:27:37] Speaker 03:
Your Honor, we did not claim a special aspect of the coding.

[00:27:43] Speaker 05:
So do you agree with your friend on the other side that your claim is so broad that you're covering everything?

[00:27:49] Speaker 03:
Your Honor, I disagree that our claim is so broad that we're covering everything.

[00:27:52] Speaker 03:
We provided sufficient written description and ambulance support to teach how to bind these nucleic acids in hybridizable form.

[00:28:00] Speaker 03:
What we're identifying is that the lack of evidence as to how, and FISH, because that's really the standard.

[00:28:06] Speaker 03:
We have to look at FISH.

[00:28:07] Speaker 03:
FISH is the protocol that they're asserting for inherently.

[00:28:10] Speaker 03:
And if there's enough information there to understand if the bases are available,

[00:28:13] Speaker 03:
and we'd submit that there's no evidence there.

[00:28:16] Speaker 03:
Turning back to the obvious combinations, I just wanted to point out that we articulated multiple reasons why these references should not be combined, and the board, you know, didn't address all of those.

[00:28:29] Speaker 03:
In fact, it typically just, you know, just maybe one and swept it away, but there were multiple reasons

[00:28:34] Speaker 03:
including the erroneous argument the board made that somehow we were attacking the references individually.

[00:28:42] Speaker 03:
We have to identify the deficiencies in the references themselves to then point out why a person of ordinary skill would not have sought to combine them.

[00:28:51] Speaker 03:
And then just moving back to our arguments regarding written description, the priority with respect to VPK, I think it's critical that the board did not address, as required in Wacopolis,

[00:29:03] Speaker 03:
level of predictability and the knowledge of a skilled artisan.

[00:29:07] Speaker 03:
And that's critical because without those findings it jumps straight to determining that the number of species in the original application were not sufficient to identify the entire genus.

[00:29:20] Speaker 03:
But that is a leap without having first assessed the level of predictability and the knowledge of a skilled artisan.

[00:29:27] Speaker 01:
Do you think the term is a generic term?

[00:29:30] Speaker 03:
I don't think it's necessarily a generic term, Your Honor.

[00:29:35] Speaker 02:
One last question.

[00:29:36] Speaker 02:
We know that a negatively charged phosphate backbone will bind to a positively charged support.

[00:29:45] Speaker 02:
Is there any evidence in the record why a base would bind to a positively charged support?

[00:29:53] Speaker 03:
Your Honor, there is some evidence that our expert pointed to about why there could be problems with the binding with the amines with respect to the bases.

[00:30:07] Speaker 01:
Thank you, Counsel.

[00:30:08] Speaker 01:
The case is submitted.